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Effects of Aster glehni Extract on Serum Uric Acid in Subjects with Mild Hyperuricemia: A Randomized, Placebo-Controlled Trial.
Journal of Medicinal Food ( IF 2.4 ) Pub Date : 2020-05-12 , DOI: 10.1089/jmf.2019.4513
Soyeon Lee 1, 2 , Eun Hye Han 2, 3 , Sang Ho Lee 2, 3 , Mi Kyung Lim 4 , Chang-O Kim 5 , Seongman Kang 1
Affiliation  

Aster glehni extracts (AGE) reduced serum uric acid levels in hyperuricemia rats in several previous studies. However, its efficacy in human has not been yet explored. This study aimed at investigating the efficacy and safety of AGE on the anti-hyperuricemia effect in subjects with slightly high serum uric acid. A randomized, double-blinded, placebo-controlled clinical trial was conducted for 12 weeks. Eligible subjects were randomly assigned to either AGE (480 mg/day) or placebo. The primary endpoint was the change in serum uric acid concentrations from baseline to follow-up time points. The secondary endpoints were the change of serum xanthine oxidase activity, and the levels of C-reactive protein (CRP) and tumor necrosis factor alpha (TNF-α) in the blood from baseline to follow-up time points. Safety was assessed by clinical laboratory parameters and adverse events reported by subjects. Six weeks of AGE supplementation significantly reduced serum uric acid level from baseline (P = .0468) but at the end of the intervention the participants did not show the beneficial effect of AGE supplementation. Also, the serum uric acid level in the AGE group was not significantly different at the follow-up time points, when compared with placebo. The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups. There were no adverse events reported by subjects or changes in safety parameters after intervention. In conclusion, AGE supplementation for 12 weeks did not show significant benefits for reducing serum uric acid concentrations in subjects with mild hyperuricemia.

中文翻译:

紫苑提取物对轻度高尿酸血症患者血清尿酸的影响:一项随机,安慰剂对照的试验。

在先前的一些研究中,紫gl提取物(AGE)降低了高尿酸血症大鼠的血清尿酸水平。然而,尚未探索其对人的功效。这项研究的目的是研究AGE对血清尿酸水平较高的受试者抗高尿酸血症作用的有效性和安全性。进行了一项为期12周的随机,双盲,安慰剂对照临床试验。将符合条件的受试者随机分配至AGE(480毫克/天)或安慰剂。主要终点是血清尿酸浓度从基线到随访时间点的变化。次要终点是血清黄嘌呤氧化酶活性,C反应蛋白(CRP)和肿瘤坏死因子α(TNF- α)水平的变化。)从基线到随访时间点的血液中。通过临床实验室参数和受试者报告的不良事件评估安全性。补充AGE六周后,血清尿酸水平明显降低(P = .0468),但在干预结束时,参与者并未显示出补充AGE的有益效果。此外,与安慰剂相比,AGE组的血清尿酸水平在随访时间点无显着差异。次要终点从基线到每个时间点的平均变化在两组之间以及两组之间均未显示出显着差异。干预后没有受试者报告不良事件或安全性参数变化。总之,补充AGE 12周对于降低轻度高尿酸血症患者的血清尿酸浓度没有明显的益处。
更新日期:2020-05-12
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